Abstract

METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF 7DM IMPURITY IN MOMETASONE FUROATE

Sujit A. Desai*, Ravindrapal Singh, Sandip B. Patil, Girish G. Desai and Prafulla B Choudhari

ABSTRACT

Objective: Objective of the present analytical research work was to develop and subsequent validate Reverse phase High Performance Liquid Chromatographic method for estimation of 7DM impurity content in Mometasone Furoate. Methods: Numerous HPLC condition were tested for estimation of 7DM, the result were achieved by using Intersil ODS C18 (50mm×4.6mm×3μm) column and mobile phase containing 0.1% TEA adjusted to pH 3 with TFA and 100% ACN in gradient mode at flow rate 1.5ml/min. at temperature 45 with UV detection at 242nm. Results: In this method the linear response was observed in range of 1.5-7.5μg/ml. with correlation coefficient of 1. Accuracy and precision were found to be satisfactory within limit for this method. The proposed method has adequate specificity and suitability. Interpretation and conclusion: The simple, sensitive, precise, rapid and specific method were developed and validated statistically for estimation of 7DM impurity in Mometasone Furoate.

Keywords: Mometasone Furoate; 7DM impurity; gradient mode; RP-HPLC.